Educo Life Sciences recently caught up with Richard Young to discuss legacy products and some of the most challenging aspects when transitioning them to comply with the new medical device regulations.

The new European Medical Device Regulations means that legacy products need to meet new requirements to maintain compliance. Not only does this require meeting new state-of-the-art but ensuring design and documentation requirements are also updated.

You can watch or read the interview below.

 

What exactly do we mean when we say transitioning legacy products?

This is a really weird thing, which is peculiar to the adoption of the new New European Medical Devices Regulations. Obviously, there are lots of medical device products out there on the market and have been for many, many years and transitioning them means moving these legacy products that have been designed and manufactured for a long period of time into compliance with the new regulations. So, the transition is getting these products and making sure that the new state-of-the-art and the new requirements of the regulations are being met by the design and documentation of these products, basically ensuring that legacy products meet state-of-the-art.

 

What is the legacy product transition process and why is it important it is done correctly?

This is a focus for regulators when they’re looking at products. Obviously, a lot of companies have a huge portfolio of products that need to go through this transition, and we need to make sure that it’s done correctly because it’s expensive to start with, and potentially expensive. Often, we find if we do things properly, we find gaps between the documentation of the existing legacy product and where it needs to be to meet the requirements of the regulation during the transition. So, we need to understand where those gaps are and what the process is going to be required to move us through that transition to successful registration of that product; for the manufacturer, that often requires some consideration of those costs and those timings, and the commercial viability of conducting that activity. Once that’s done, it’s ensuring that the resources and plan are in place to deliver, addressing all those gaps so that at the end of that process, the compliance with the new regulations, is established, and we can move forward successfully and not worry about the transition anymore.

 

What would you say are some of the biggest challenges when transitioning legacy products and how would you mitigate these?

The biggest problems we’ve got, or the biggest challenges we’ve got in transitioning legacy products to compliance with the new regulation, is that technology and understanding have moved and changed, both in terms of the regulation itself. If nothing had changed, we wouldn’t need a new regulation. Also, in terms of the state of the art, our understanding of how we do things now versus how we might have done something 15, 20 years ago has also changed. A great example of that, from a standards perspective, is how we approach biocompatibility of patient contacting devices now and how we document that has changed significantly in the latest version of standards, and bridging that gap between what we have before and what we need to go forward can often be a bit of a challenge, and require maybe additional testing or something like the intervention from a registered toxicologist, to conduct an assessment against the new state of the art, and allow us to draw a conclusion, as to the current status of compliance of that element, that aspect of the product design and testing.

We also have a different emphasis there from a regulatory perspective, there’s a great deal of emphasis in the new regulation on clinical evidence, and we will often find that the amount of clinical evidence that’s available for a legacy product may not be meeting the expectations that regulators might have now. So, there’s quite a large gap and addressing that gap and maintaining data over the continued life of the product require potentially big investments that the manufacturer must do to take things forward. There are many more, and those are two of the big ones, but where we’re going here is we need to understand what the current state of the art is, and then we need to have a plan, a costed plan, that allows us to address these gaps to the point where we can submit the revised product to the notified bodies for assessment and compliance with the new regulations.

 

What are critical design inputs?

That’s a very good question. Design inputs, in terms of legacy products, often aren’t very well stated. So, whether it be for a new product development or a legacy product, it’s really important to ensure that we’ve got a complete set of design inputs that unambiguously describe the product. Often, from a consultation point of view, we find a lot of problems in the design and development process and the subsequent regulatory assessment, where the intended purpose, the intended use, the intended user and the intended use environment of the device are not adequately expressed in the design of the product, and that’s based on the design inputs.

Now we’ve got many places design inputs can come from, they can come from our users, and our customers. They can come from state-of-the-art standards that have performance requirements that we may need to demonstrate compliance. They could also come from standards where safety is being proven by meeting certain levels of performance, like electrical safety is a great example of that.

And critically, we might be getting inputs from things like assessment of risk management, from clinical evidence where we’re finding out what has gone wrong before, where risks are, what design features are required for a product that’s meeting a particular user need and from usability. And that’s sort of a really developing area, the usability of our product and our assessment of that is going to drive design inputs and design solutions to ensure that our users can work with our products better than they have maybe with older designs.

So, yes, a lot of places we can get design inputs from, they’re all critical. We really need to get those right and have a very broad, global look at all these sources to make sure that we have the best expression of design inputs possible before we embark on the development of the product, or indeed all the documentation of a legacy product where this may not have been done adequately in the past. So, it’s a really important step in the design and development of any product and its ongoing maintenance as well.

 

What are the process standards and why is it critical to incorporate those into your design plan?

We’ve mentioned a couple of inputs, and there are many processes, I’m going to talk about, three of them here. We all understand risk management as a process standard, and risk management is a process that we apply to the design and development of the product and throughout the product’s entire lifecycle, so it’s something we continuously, work with and update. We’re used to that, we’ve got a couple of other process standards that also have a massive influence that are the basis if we’re submitting products to the FDA. For instance, the absence of evidence that we followed these process standards would be grounds for refusal of an application for conformity assessment.

Now, the two I’m thinking about here are the ones we’ve mentioned already, usability or human factors engineering, the standard for that is IEC 62366, and there are two parts that were published in 2015. That’s a process standard and it dictates how we approach the design process and how we take into consideration the design inputs we’re generating from usability concerns, how we’re incorporating those and assessing them through risk management, and how we build a body of evidence that we’ve designed those features of the product correctly throughout the design process all the way through to the final design validation that demonstrates we’ve implemented those usability and human factors elements correctly at the end of the process. So, it starts from the design inputs, and it goes all the way through and it’s one of those standards that’s almost impossible to prove compliance with. If you try and do it at the end it will be wrong as it’s meant to be applied as a process alongside design throughout.

Very similar to that is if you’re involved in the development of products that contain, or are software based. Again, the standard is IEC 62304. That’s the standard that we use for the development of software and it dictates a process approach so we start thinking about how we’re building the software right from the initial idea of the product and we produce documentation as evidence that we’ve gone through the stages as the designs evolved and to the point where we validate the finished product at the end of the process. Again, both process standards are very, very, very difficult to apply at the last minute, it’s something we need to be doing right from the beginning and taking through. There’s good reasons to do it this way, and process standards lead us to much better medical products in the market.

 

How will the Medical Device Design & Development for New & legacy Products help people working in the medical device industry be prepared for facing some of the most common challenges we have discussed?

I think it’s really important when you’re looking at either new product development or legacy products development, to have a really good understanding of the basics of a design and development process. It enables you to interpret and manipulate that system and get your inputs right so you can successfully navigate your way through and at the end of the day, produce a lot of documented evidence that demonstrates that you have done things properly. The whole point of the design and development process is to create several things. One is a load of documentation, evidence, and objective evidence that you’ve taken a systematic approach to the design process and that’s great. That’s something that we do for the regulators as evidence and that’s something we put in a design history file, and that’s great, we need to be able to do that.

But from the course, we also need to understand that the elements of the design process, whether it be the process standards or the central concepts of design itself, aren’t just something we’re doing just to keep regulators happy, they’re actually really good ways of developing products and ensuring that we do things in a systematic and organised manner, and most fundamentally, these mechanisms that help us record and communicate between team members to ensure that there are no ambiguities and that we conduct these processes to regulators standards, but in the most efficient way we possibly can.

So, we don’t want to miss things, we don’t want to forget to do certain actions, and we want to make sure that we’re reviewing and ensuring we’re doing the best possible job as we go through and we’re transferring at the end of the process well-designed products into manufacturing that are going to meet customer’s needs.

So that’s the point of it. Communication, teamwork, documentation, the most important thing about it is communication and teamwork and if we get that right, we get a good set of documentation in our design history file to keep the regulators happy as well.

 

Watch the interview below:

 

 

Richard teaches the following courses:

Regulatory Affairs for Combination Products (Drug/Device and Device/Drug)

Fundamentals of the EU IVD Regulation (IVDR)

Labelling and UDI for Medical Devices and IVDs

Medical Device Design and Development for New and Legacy Products

 

 

To view all our medical device and IVD courses follow the link below.

View our medical device & IVD training courses